This Funding Opportunity Announcement (FOA) (PAR-23-032) solicits Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that translate technology and therapeutic innovations from academic and other non-profit research sectors to the marketplace to advance the development of diagnostic and prevention tools or treatments for musculoskeletal, rheumatic or skin diseases.

1. Who can apply?

Since this FOA uses the NIH SBIR grant mechanism, the applicants must be eligible small business companies. The academic and other non-profit research institutions cannot apply, but can be a collaborator to complete the project.

2. What is a late-stage translation?

For the purpose of this FOA, a late-stage translation is continuation of previous research work that has shown promising data for development of a product. It is expected that the academic/non-profit labs have conducted mechanistic studies and obtained preliminary results that provide a strong premise to further develop the technology or therapy. The concept of a product should be well defined.

3. What are the major differences between this FOA and the NIH SBIR Omnibus/Parent FOA?

  1. There are additional review criteria (See question 4 below).
  2. This FOA allows a bigger budget cap than the parent SBIR FOA. The cap for Phase I awards increases from $275K to $300K for 6 months to one year. The cap for Phase II awards increases from $1.83M to $2M for 2 years. Any research topics with a budget over the Statutory Budget Limitations must be listed on the Waiver Topics approved by the SBA (https://sbir.nih.gov/funding#omni-sbir).

4. What are the additional review criteria?

  1. This FOA requires milestones for both phase I and phase II applications, while the parent SBIR FOA only requires milestones in a phase I application. A phase II application should propose clear, appropriate, measurable goals (milestones) toward receiving regulatory approval for clinical testing or making the product practical to use in a clinical setting.
  2. The applicant should have an Intellectual Property licensing agreement for the technology transfer from the academic/non-profit institution.
  3. The application should propose collaborative support from the academic/non-profit lab to complete the project. The collaborative support includes, but not limited to the use of multiple Program Directors/Principal Investigators for the academic/non-profit lab to perform a small portion of the project. This FOA also encourages the company to employ academic researchers, especially women and socially or economically disadvantaged persons, to participate in innovation and entrepreneurship.

5. What factors should I consider when choosing this FOA over STTR for the technology transfer?

This FOA uses the SBIR grant mechanism, which allows only one third of the work in the phase I and one half in the phase II to be subcontracted out.  Therefore, it requires substantial research and development work to be done by the small business company. If the company needs to subcontract out a major portion of the work (up to 60%), it should apply for the STTR funding opportunities.

6. Can I propose clinical trials?

No. Applications may include human subjects research; however, clinical trials are excluded. Applicants could propose to analyze samples from affected subjects and controls, conduct subject interviews or other procedures of clinical research; however, applications that propose to conduct intervention studies will not be considered responsive to the FOA and will not be reviewed.

7. What are the due dates?

The due dates are the same for the parent SBIR FOA. They are Jan. 5th, April 5th, and Sept. 5th.

8. What is the active period of the FOA?

The FOA will be active in 2023 to 2026. It will be expired on September 06, 2026.

Contact Us

Xibin Wang, Ph.D.

Program Director
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Last Updated: October 2022